FDA Grapples with Future Regulation of 3-D Printed Medical Devices

As the concepts of patient matching and on-demand 3-D printing of medical devices in healthcare facilities inch closer to reality, FDA tries to determine its role and how to regulate products produced using additive manufacturing.

Although a number of 3-D printed medical devices have received 510(k) clearance through the existing regulatory pathway, novel technologies in development will require new regulatory considerations, Steven K. Pollack, director of the Office of Science & Engineering Labs at FDA, said during a presentation at MD&M East this week.

"Right now, the devices that we've seen coming through the pipeline with additive manufacturing really don't raise for us any major red flags that say additive manufacturing is a new problem that we have to think about very differently," Pollack said. "But we're out there really trying to address what this technology brings to us."

In particular, the agency identifies mechanical properties, biocompatibility, and interactive design as areas of additive manufacturing that it's keeping an eye on. Mechanical testing questions may arise with medical devices produced using additive manufacturing, for instance, that wouldn't with conventional manufacturing methods, Pollack said. The same goes for biocompatibility.

But as more complex devices are developed and 3-D printing allows for on-demand patient matching or customization, the most pressing issue for FDA centers on engineering versus clinical decisions, according to Pollack. "Where is the point where the machine building the device becomes an extension of the clinician?"

To illustrate this point, Pollack described a potential future scenario in which a clinician simply goes to an area within the medical facility for a custom implant sized for a specific patient, but perhaps with slight modifications based on the clinician's input or preference.

This on-demand printing scenario prompts several questions and concerns from a regulatory perspective, according to Pollack. "Who is the manufacturer?" he mused. "What are going to be FDA's roles in looking at the controls for what would potentially be manufactured in a [healthcare] facility? On the shop floor, there may be one level of quality control, but in a medical institution, it may not be as well set up."

But it's imperative to ensure that 3-D printed medical devices are safe and effective—regardless of where they're manufactured, Pollack stressed. Ultimately, he noted, these on-site-printed devices would need to be reproducible and have a valid design; quality control processes will also need to be in place for the manufacture of the product.

FDA has created an additive manufacturing working group to explore some of these issues, ensure consistency across the agency, and develop policy for the regulation of the field. However, Pollack noted that FDA is actively seeking assistance from industry and academia to identify potential technological challenges and solutions for producing novel medical devices using 3-D printing. The agency will hold an additive manufacturing workshop and Webinar in October with this purpose that will help shape a future technical guidance.

"[We would like to be] aware of the challenges and don't regulate things that don't need regulation," Pollack said. "But we need to be aware of places where we need to take a deeper dive."